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The Barricade Embolization Coil System is intended for the endovascular embolization of intracranial anewysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. The Barricade Embolization Coil System is also intended for vascular occlusion of blood vessels within the neurovascular system to permanently obstruct blood flow to an aneurysm or other vascular malformation and venous embolizations in the peripheral vasculature.

The Barricade Embolization Coil System (BCS) is a series specialized coils that are inserted into the vasculature under angiographic visualization to embolize intracranial aneurysms and other vascular anomalies. The system consists of an embolization coil implant comprised of platinum/tungsten, affixed to a delivery pusher with an introducer sheath to facilitate insertion into the hub of a microcatheter. The system is available in various shapes, lengths and sizes. The devices are to be placed into aneurysms to create blood stasis, reducing flow into the aneurysm and thrombosing the aneurysm. Upon positioning coils into the aneurysm, the coils are electrolytically detached from the delivery pusher in serial manner until the aneurysm is occluded.

This document describes the Barricade Embolization Coil System, a medical device, and its acceptance criteria as demonstrated by performance data. It is a 510(k) Summary, meaning the device is being compared to previously cleared predicate devices to establish substantial equivalence.

Here's the breakdown of the requested information:

1. A table of acceptance criteria and the reported device performance

The document doesn't provide a direct "acceptance criteria" table with specific numerical limits for each test. Instead, it states that the modified device met all specified criteria and performed as intended, demonstrating substantial equivalence to the predicate devices. The performance data section lists the types of tests conducted and concludes that the modified device "met all specified criteria and did not raise new safety or performance questions."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample size: The document does not explicitly state the sample size for the "test units representative of finished devices."
• Data provenance: The document does not specify the country of origin of the data or whether the study was retrospective or prospective. It describes "comparative simulated use testing," which implies laboratory or in-vitro testing rather than human clinical data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the document. The testing described (visual inspection, dimensional measurement, simulated use, tensile tests) does not typically involve expert review for "ground truth" in the way clinical studies or diagnostic AI algorithms do. It's focused on engineering and performance specifications.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided and is not applicable to the type of engineering and performance testing described. Adjudication methods are typically used in clinical studies where multiple human readers interpret data that may be ambiguous.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

There was no MRMC comparative effectiveness study and no discussion of human readers or AI assistance. This device is a physical medical device (embolization coils), not an AI algorithm for diagnosis or interpretation.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This question is not applicable as the device is a physical embolization coil system, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The concept of "ground truth" as it applies to an AI model or diagnostic test is not directly applicable here. For this physical device, the "truth" is whether it meets its engineering specifications and performs its intended function safely and effectively in simulated environments. This would be verified through:

• Engineering specifications and measurements (dimensional, tensile).
• Functional performance in controlled simulated environments (e.g., fluid dynamics models for embolization).

8. The sample size for the training set

This information is not applicable. The device is a physical product, not an AI model that requires a training set.

9. How the ground truth for the training set was established

This information is not applicable as there is no training set for this physical device.

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